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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K844005
Device Name ARM-A-VIAL LV HEATER-BREATHING SYS
Applicant
Armour Pharmaceutical Co.
303 S. Braodway
Tarrytown,  NJ  10591
Applicant Contact DAVID MARCUS
Correspondent
Armour Pharmaceutical Co.
303 S. Braodway
Tarrytown,  NJ  10591
Correspondent Contact DAVID MARCUS
Regulation Number868.5270
Classification Product Code
BZE  
Date Received10/12/1984
Decision Date 11/08/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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